Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-17
SponsorNorthwestern University
About this trial
Single center, prospective, Open label study of sleep, pruritus and circadian function pre/post 12-weeks of dupilumab treatment in children 6-17 years old
Eligibility criteria
Qualifiers
Participants, 6-17 years old at time of enrollment.
Moderate to severe chronic AD inadequately controlled by topical treatment, diagnosed according to Hanifin and Rajka criteria by a pediatric dermatologist or allergist.
AD severity will be determined at baseline with Validated Investigator Global Assessment (vIGA) score of moderate (3) or severe (4).
Patient assessed or parent-proxy (under 8 years old) PROMIS sleep disturbance T-score ≥60.
Disqualifiers
Poorly controlled asthma (Asthma Control Test ≤19).
Self-reported sleep disturbance on 2 or more nights in the past 7 days due to allergic rhinitis.
Use of concomitant medication that causes scratching.
Major medical condition (such as cancer).
Trial design
Treatments tested in this trial
- Dupilumab
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Northwestern University
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov